The following data is part of a premarket notification filed by Andrew Technologies, Llc with the FDA for Phaser Lipoplasty System (dur-01), Phaser Disposable Kit (dis-01), Phaser Waste Collection Kit (was-01), Phaser Cannulae.
| Device ID | K092066 |
| 510k Number | K092066 |
| Device Name: | PHASER LIPOPLASTY SYSTEM (DUR-01), PHASER DISPOSABLE KIT (DIS-01), PHASER WASTE COLLECTION KIT (WAS-01), PHASER CANNULAE |
| Classification | System, Suction, Lipoplasty |
| Applicant | ANDREW TECHNOLOGIES, LLC 555 13TH ST., NW Washington, DC 20004 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan ANDREW TECHNOLOGIES, LLC 555 13TH ST., NW Washington, DC 20004 |
| Product Code | MUU |
| CFR Regulation Number | 878.5040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-08 |
| Decision Date | 2010-04-12 |
| Summary: | summary |